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Guangdong Qisitech Co., LTD.

⚠️ High Risk

FEI: 3018527601 • Dongguan, Guangdong • CHINA

FEI

FEI Number

3018527601

📍

Location

Dongguan, Guangdong

🇨🇳

Country

CHINA
🏢

Address

Building 3, No 36, Fuxing Road, Room 201, Changa'an Town, Dongguan, Guangdong, China

High Risk

FDA Import Risk Assessment

66.3
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

20
Total Refusals
3
Unique Violations
8/4/2025
Latest Refusal
7/19/2023
Earliest Refusal

Score Breakdown

Violation Severity
59.3×40%
Refusal Volume
49.0×30%
Recency
90.9×20%
Frequency
97.7×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

384220×

TP NO PMTA

This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it is a tobacco product that FDA has found to be adulterated under section 902(6)(A) of the FD&C Act in that it does not have an FDA marketing order in effect under section 910(c)(1)(A)(i) of the FD&C Act.

384319×

TP NO SE

This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it is a tobacco product that FDA has found to be misbranded under section 903(a)(6) of the FD&C Act in that a notice or other information respecting it was not provided as required by section 905(j).

38541×

TPLKUSSLLB

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act because it is a tobacco product in package form that appears to be misbranded under section 903(a)(2)(D) of the FD&C Act in that the label does not provide the statement "sale only allowed in the United States" and the tobacco product is not subject to any exemptions or variations.

Refusal History

DateProductViolationsDivision
8/4/2025
98LCA01E-CIGARETTE
3842TP NO PMTA
3843TP NO SE
3854TPLKUSSLLB
Division of Northern Border Imports (DNBI)
10/11/2024
98LCA99ELECTRONIC NICOTINE DELIVERY SYSTEM, NEC
3842TP NO PMTA
3843TP NO SE
Division of Northern Border Imports (DNBI)
10/11/2024
98LCA99ELECTRONIC NICOTINE DELIVERY SYSTEM, NEC
3842TP NO PMTA
3843TP NO SE
Division of Northern Border Imports (DNBI)
10/11/2024
98LCA99ELECTRONIC NICOTINE DELIVERY SYSTEM, NEC
3842TP NO PMTA
3843TP NO SE
Division of Northern Border Imports (DNBI)
10/11/2024
98LCA99ELECTRONIC NICOTINE DELIVERY SYSTEM, NEC
3842TP NO PMTA
3843TP NO SE
Division of Northern Border Imports (DNBI)
10/11/2024
98LCA99ELECTRONIC NICOTINE DELIVERY SYSTEM, NEC
3842TP NO PMTA
3843TP NO SE
Division of Northern Border Imports (DNBI)
10/11/2024
98LCA99ELECTRONIC NICOTINE DELIVERY SYSTEM, NEC
3842TP NO PMTA
3843TP NO SE
Division of Northern Border Imports (DNBI)
10/11/2024
98LCA99ELECTRONIC NICOTINE DELIVERY SYSTEM, NEC
3842TP NO PMTA
3843TP NO SE
Division of Northern Border Imports (DNBI)
10/11/2024
98LCA99ELECTRONIC NICOTINE DELIVERY SYSTEM, NEC
3842TP NO PMTA
3843TP NO SE
Division of Northern Border Imports (DNBI)
10/11/2024
98LCA99ELECTRONIC NICOTINE DELIVERY SYSTEM, NEC
3842TP NO PMTA
3843TP NO SE
Division of Northern Border Imports (DNBI)
10/11/2024
98LCA99ELECTRONIC NICOTINE DELIVERY SYSTEM, NEC
3842TP NO PMTA
3843TP NO SE
Division of Northern Border Imports (DNBI)
8/28/2024
98LCA11VAPE PEN
3842TP NO PMTA
3843TP NO SE
Division of West Coast Imports (DWCI)
8/28/2024
98LCA11VAPE PEN
3842TP NO PMTA
3843TP NO SE
Division of West Coast Imports (DWCI)
8/28/2024
98LCA11VAPE PEN
3842TP NO PMTA
3843TP NO SE
Division of West Coast Imports (DWCI)
8/28/2024
98LCA11VAPE PEN
3842TP NO PMTA
3843TP NO SE
Division of West Coast Imports (DWCI)
8/28/2024
98LCA11VAPE PEN
3842TP NO PMTA
3843TP NO SE
Division of West Coast Imports (DWCI)
8/28/2024
98LCA11VAPE PEN
3842TP NO PMTA
3843TP NO SE
Division of West Coast Imports (DWCI)
8/28/2024
98LCA11VAPE PEN
3842TP NO PMTA
3843TP NO SE
Division of West Coast Imports (DWCI)
8/28/2024
98LCA11VAPE PEN
3842TP NO PMTA
3843TP NO SE
Division of West Coast Imports (DWCI)
7/19/2023
98LCA01E-CIGARETTE
3842TP NO PMTA
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is Guangdong Qisitech Co., LTD.'s FDA import refusal history?

Guangdong Qisitech Co., LTD. (FEI: 3018527601) has 20 FDA import refusal record(s) in our database, spanning from 7/19/2023 to 8/4/2025.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Guangdong Qisitech Co., LTD.'s FEI number is 3018527601.

What types of violations has Guangdong Qisitech Co., LTD. received?

Guangdong Qisitech Co., LTD. has been cited for 3 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Guangdong Qisitech Co., LTD. come from?

All FDA import refusal data for Guangdong Qisitech Co., LTD. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.